Prospective Observational Study of Mobile App-Based Patient-Reported Outcomes in Advanced Breast Cancer in Asia (MADELINE ASIA)

Study identification

• EU PAS number:
  EUPAS23593
• Study ID:
  50391
• Official title and acronym:
  Prospective Observational Study of Mobile App-Based Patient-Reported Outcomes in Advanced Breast Cancer in Asia (MADELINE ASIA)
• DARWIN EU® study:
  No
• Study countries:
  Hong Kong

  India

  Malaysia

  Taiwan
• Study description:
  Prospective Observational Study of Mobile App-Based Patient-Reported Outcomes in Advanced Breast Cancer in Asia. The primary objectives are to assess and describe clinical and patient-reported outcomes (PROs) in women with locally advanced/unresectable or metastatic (ABC/mBC) HR+/HER2– breast cancer receiving palbociclib in combination with an aromatase inhibitor or fulvestrant as per product label.
• Study status:
  Finalised

Research institutions and networks

Institutions

Multiple centres: 11 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:17/12/2017

Actual:17/12/2017

Study start date

Planned:01/10/2019

Actual:12/03/2020

Data analysis start date

Planned:01/06/2022

Actual:12/03/2020

Date of final study report

Planned:01/12/2022

Actual:01/12/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable